BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1080736 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00579
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: OTHER - LACK OF INFO (NO FILMS OR OPERATIVE REPORTS WERE PROVIDED). (MIGRATION). OTHER - LOCK OF INFO (NO FILMS OR OPERATIVE REPORTS WERE PROVIDED). OTHER - (REQUIRES SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    AN UNK SIZE TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 25 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. ON A RECENT FOLLOW-UP APPROX 1 MONTH AGO, IT WAS REPORTED THE STENT GRAFT HAD MIGRATED. NO ADD'L INFO WAS PROVIDED AND NO ADD'L CLINICAL SEQUELAE WERE REPORTED. ALTHOUGH THE MODEL NUMBER FOR THE DEVICE MENTIONED IN THIS EVENT WAS NOT REPORTED, THIS PRODUCT WAS NOT MARKETED IN THE US IN 2006; THEREFORE, THE MODEL USED IN THE EVENT IS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention